Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Deep Brain Stimulation, Obsessive Compulsive Disorder, Nucleus Accumbens
Eligibility Criteria
Inclusion Criteria:
- Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis
- severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale
- course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance)
- treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency
- the ability to give written and informed consent
Exclusion Criteria:
- co-morbid psychotic disorder according to DSM-IV criteria
- suicidal tendencies in the last 6 months
- history of cerebral trauma
- clinically relevant internal or neurological disorder
- substance misuse or dependence in the last six months
- ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
- pregnancy
- lactation period
Sites / Locations
- Department of Psychiatry, University of Cologne
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale
Secondary Outcome Measures
Beck Depression Inventory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724490
Brief Title
Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
Official Title
Unilateral Deep Brain Stimulation of the Nucleus Accumbens in Patients With Treatment Resistant Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study was to evaluate whether a unilateral Deep Brain Stimulation of the right Nucleus Accumbens could lead to a more than 35% reduction of symptoms in patients with a treatment resistant Obsessive Compulsive Disorder within two years.
Detailed Description
From the late ninety's on, a few work groups published the case series of patients with treatment resistant OCD undergoing deep brain stimulation (DBS). This stereotactical method involves surgically implanted electrodes and previously has been used primarily for the treatment of Parkinson's disease and tremor.
In almost all reported cases, a bilateral stimulation in the anterior limb of the internal capsule (ALIC was applied. However, the electrode designs between the groups varied and in some cases the stimulation area was extended to the adjacent ventral striatal regions including the nucleus accumbens (NAC).
Cortical-striate-thalami-cortical (CSTC) circuits are supported to be implicated in the pathogenesis underlying OCD caused by a failure of inhibition of the ventral striatum. Together with other structures the nucleus accumbens forms the ventral striatum. Because of the predominant role of the NAC to exert modulatory effects within these circuits we considered it to provide a promising target location for DBS.
Moreover the NAC ventrally borders with the anterior limb of the internal capsule and the subventricular lateral fundus of the nucleus accumbens is even permeated in rostral sections by numerous internal capsule fiber bundles. It was therefore to be expected that the electrode trajectories and stimulation target selected by us additionally would have an effect on the fibre systems of the internal capsule.
The NAC had been introduced as primary target for DBS in treatment resistant OCD by our group. Pilot series showed that the right stimulation of the NAC yielded the best results, whereas bilateral stimulation showed no additional benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Deep Brain Stimulation, Obsessive Compulsive Disorder, Nucleus Accumbens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
Model 3387 DBS Lead, Medtronic, Minneapolis, USA
Intervention Description
Unilateral Deep Brain Stimulation in the right Nucleus Accumbens
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale
Time Frame
Baseline (preoperative), 1week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
Baseline (preoperative), 1 week, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis
severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale
course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance)
treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency
the ability to give written and informed consent
Exclusion Criteria:
co-morbid psychotic disorder according to DSM-IV criteria
suicidal tendencies in the last 6 months
history of cerebral trauma
clinically relevant internal or neurological disorder
substance misuse or dependence in the last six months
ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
pregnancy
lactation period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Klosterkötter, MD
Organizational Affiliation
Department of Psychiatry, Head of Department, University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Unilateral Deep Brain Stimulation (DBS) of the Nucleus (Nucl.) Accumbens (Acc.) in Patients With Treatment Resistant Obsessive Compulsive Disorder (OCD)
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